EMEA-002722-PIP01-19-M03 - paediatric investigation plan

Etranacogene dezaparvovec

Key facts

• Active substance:
  Etranacogene dezaparvovec
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0368/2023
• PIP number:
  EMEA-002722-PIP01-19-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Haemophilia B
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0368/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for etranacogene dezaparvovec (Hemgenix), (EMEA-002722-PIP01-19-M03)

Adopted Reference Number: EMA/385723/2023